BSD Medical Corporation (NASDAQ: BSDM) (Company or BSD) today announced that it has received review questions from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission the Company filed for premarket clearance of the Company's Phase II MicroThermX® Microwave Ablation System (MTX-180) for ablation of soft tissue.
"We expected questions from the FDA as a routine part of the 510(k) submission review process," stated Harold Wolcott, President of BSD. "We plan to provide a timely response to the questions from the FDA. While we cannot predict the ultimate outcome or when the review will be completed, we are optimistic about the outcome."
The clearance from the FDA of the 510(k) submission will authorize commercial distribution of the MTX-180 in the United States and allow the Company to provide an optimized system targeted to the growing therapeutic interventional oncology market. The interventional oncology world-wide market for 2009 was estimated at $210 million, and this market is projected to grow to $480 million by 2015.
The MTX-180 employs precision-guided microwave energy to ablate (destroy) soft tissue using a single-patient-use disposable antenna. The MTX-180 was developed to provide treatments as a stand-alone therapy.
Six common flying with food allergies myths